BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 19069525 · Received April 9, 2024

    Report

    Report Number
    3010457505-2024-00270
    Event Type
    Injury
    Date Received
    April 9, 2024
    Date of Event
    March 11, 2024
    Report Date
    April 29, 2024
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    UDI-DI
    07290107981194
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE RECEIVED ADDITIONAL INFORMATION FROM THE PRESCRIBING PHYSICIAN ON APRIL 08, 2024, THAT THE PATIENT EXPERIENCED DISEASE PROGRESSION, WHICH WAS MOST LIKELY THE CAUSE OF THE PRIOR HOSPITALIZATION. THE PATIENT HAD NOT RESUMED OPTUNE GIO THERAPY.

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT AS THE PATIENT WAS ON OPTUNE GIO THERAPY AT THE TIME OF THE REPORTED ELECTRIC SHOCK, A CONTRIBUTION OF THE DEVICE TO THE EVENTS CANNOT BE RULED OUT. REVIEW OF THE DEVICE LOGFILE SHOWS LAST PATIENT USE OF (B)(6) ON (B)(6) 2024 AT 01:06:48. NO ERRORS OR PERFORMANCE ISSUES WERE RECORDED AT THIS TIME. JUST BEFORE THE LAST USE OF THERAPY ON (B)(6) 2024 AND AROUND 30 MINUTES BEFORE THERAPY WAS STOPPED, THERE WERE SIGNS OF ARRAY TO SKIN CONTACT ISSUES. TEMPERATURE TARGETS AND RESISTANCE THRESHOLDS WERE ALL IN RANGE AND THERAPY WAS OPERATING AS EXPECTED. THE TEMPERATURES AND TEMPERATURE DIFFERENTIALS HAD IMPROVED AT THE TIME THERAPY WAS STOPPED. LOG FILE REVIEW DID NOT SHOW ANY UNEXPECTED ERRORS OR BEHAVIOR THAT WOULD EXPLAIN THE PATIENT REPORT. CHOKING IS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE (EF-11 0% AND <1% EF-14 OPTUNE ARM). DRY MOUTH IS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE (EF-11 0% AND 1% EF-14 OPTUNE ARM). ELECTRIC SHOCK WAS NOT REPORTED AS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE IN THE (EF-11 OR EF-14 TRIAL IN OPTUNE ARM). THERE HAVE BEEN 100 REPORTS OF ELECTRIC SHOCK IN THE COMMERCIAL PROGRAM TO DATE.

    Description of Event or Problem · 0

    A 73-YEAR-OLD MALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. ON (B)(6) 2024, PATIENT´S SPOUSE REPORTED THE PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT DUE TO SEVERE HEADACHES, DIZZINESS, AND VISUAL DISTURBANCES. A CT SCAN RULED OUT BRAIN HEMORRHAGE. OPTUNE GIO WAS TEMPORARILY DISCONTINUED. ON (B)(6) 2024, THE PATIENT RESUMED OPTUNE GIO THERAPY AND EXPERIENCED WARMTH AND PAIN IN THE AREA OF THE PREVIOUS SURGICAL RESECTION (LAST SURGICAL RESECTION (B)(6) 2023, TUMOR LOCATION RIGHT TEMPORAL-INSULAR) EXTENDING TO THE EYES. ON (B)(6) 2024, THE PATIENT REPORTEDLY EXPERIENCED AN ELECTRIC SHOCK FROM THE TEETH TO THE THROAT RESULTING IN A CHOKING FEELING AND DRY MOUTH. THE PATIENT HAD SEVERAL DENTAL IMPLANTS. ON (B)(6) 2024, THE PATIENT WAS HOSPITALIZED AS HE WAS NOT ABLE TO SPEAK, AND HIS FACE WAS "CONTORTED" ON THE LEFT SIDE. OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. ON (B)(6) 2024, THE PHYSICIAN REPORTED THE PATIENT'S FACIAL PARESIS HAD IMPROVED. CEREBRAL EDEMA WAS SUSPECTED PER MRI FROM (B)(6) 2024. THE PHYSICIAN WANTED TO RETRY OPTUNE GIO IF THE PATIENT AGREED. ON (B)(6) 2024, THE PATIENT WAS ADVISED BY A DIFFERENT PHYSICIAN TO DISCONTINUE OPTUNE GIO THERAPY AS IT WAS UNKNOWN IF OPTUNE GIO HAD CONTRIBUTED TO THE EVENTS. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN WITHOUT A REPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2423763 OPTUNE GIO OPTUNE GIO NZK NOVOCURE GMBH TFH9100 07290107981194

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention| H APIXABAN| CANDESARTAN| METAMIZOLE SODIUM HYDRATE| METOPROLOL| SIMVASTATIN| TEMOZOLOMIDE| TORASEMIDE